- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Health Canada Approves First Omalizumab Biosimilar
Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
Health Canada has approved Omlyclo, the first omalizumab biosimilar in the Great White North, according to a statement from the biosimilar’s developer, Celltrion.1
Xolair, a blockbuster drug for allergic asthma and chronic urticaria, generated $3.7 billion in global sales in 2022. | Image credit: Pixel-Shot - stock.adobe.com
The approval enables the use of the biosimilar for treating adults and adolescents with chronic idiopathic urticaria (CIU), also known as chronic spontaneous urticaria (CSU), as well as adult and pediatric patients with allergic asthma and adults with chronic rhinosinusitis with nasal polyps (CRSwNP).
“Diseases such as CIU have substantial detrimental effects on the quality of life for patients, often impacting both their physical and emotional well-being. Over the last two decades, omalizumab has been the only anti-[immunoglobulin E] antibody that has been approved for chronic idiopathic urticaria (CIU) and asthma, and there still remains an unmet medical need for a diverse array of allergic diseases,” said Elea Netchiporouk, MD, MSc, FRCPC, assistant professor of Department of Medicine, Division of Dermatology, McGill University Health Centre. “I am pleased that Omlyclo is now approved as the first omalizumab biosimilar in Canada.”
The approval was based on results from a double-blind, randomized, active-controlled, parallel group, phase 3 study (NCT04426890), during which Celltrion confirmed the bioequivalence of CT-P39 to Xolair in patients with CSU.2 The trial, conducted in 6 countries, including Poland and Bulgaria, involved 619 patients with CSU. CT-P39 demonstrated similar results to Xolair in terms of efficacy, safety, pharmacokinetics, and immunogenicity, meeting the pre-defined equivalence criteria.
Omlyclo is also under review with the FDA after the agency accepted a biologics license application for the product in March 2024.3
Additional Celltrion Progress
In addition to the Canadian approval, Celltrion announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for 3 other Celltrion biosimilars: an aflibercept, a denosumab, and a tocilizumab.4
The company said that the milestone highlights Celltrion's dedication to advancing biosimilars and making biologic treatments more accessible across Europe.
Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, has been recommended for the treatment of retinal disorders, including wet age-related macular degeneration (AMD) and diabetic macular edema (DME). A phase 3 study demonstrated that Eydenzelt is equivalent to Eylea in terms of efficacy, safety, and immunogenicity. If approved, Eydenzelt would be among the first aflibercept biosimilars available in Europe.
Similarly, Stoboclo (CT-P41, denosumab) and Osenvelt (CT-P41, denosumab), biosimilars to Prolia and Xgeva, respectively, have been recommended for all indications of their reference products, such as osteoporosis. A Phase III trial confirmed that these biosimilars offer equivalent efficacy, safety, and pharmacokinetics to denosumab.
Lastly, Avtozma (CT-P47, tocilizumab), a biosimilar to RoActemra, is recommended for all reference indications, including rheumatoid arthritis and juvenile idiopathic arthritis. Comprehensive data showed no clinically meaningful differences in efficacy, safety, or pharmacokinetics between Avtozma and its reference product.
“With CHMP approvals for Eydenzelt, Avtozma, and Prolia/Xgeva biosimilars, Celltrion solidifies its leadership in the European biosimilar market, offering one of the most extensive antibody biosimilar portfolios. Our vertically integrated model ensures supply chain stability while addressing the specific challenges faced by European healthcare professionals and patients. These approvals underscore our commitment to supporting European healthcare systems by improving access to high-quality, affordable treatments,” said Taehun Ha, vice president and head of Europe at Celltrion.
References
1. Health Canada approves Celltrion’s Omlyclo™ (CT-P39), the first and only omalizumab biosimilar in Canada. Press release. Celltrion; December 09, 2024. Accessed December 13, 2024. https://www.businesswire.com/news/home/20241209055611/en/Health-Canada-approves-Celltrion%E2%80%99s-Omlyclo%E2%84%A2-CT-P39-the-first-and-only-omalizumab-biosimilar-in-Canada
2. Celltrion confirms bioequivalence for CT-P39 against Xolair in interim results of phase 3 study. Korea Biomedical Review. Published April 10, 2024. Accessed December 13, 2024. https://www.koreabiomed.com/news/articleView.html?idxno=20848
3. Eye on Pharma: biosimilar Ozempic; Celltrion omalizumab biosimilar submission. The Center for Biosimilars®. Accessed April 4, 2024. Accessed December 13, 2024. https://www.centerforbiosimilars.com/view/eye-on-pharma-biosimilar-ozempic-biocon-mylan-merger-celltrion-omalizumab-biosimilar-submission
4. Celltrion receives positive CHMP opinion for three biosimilars in the European. Press release. Celltrion; Published December 13, 2024. Accessed December 13, 2024. https://finance.yahoo.com/news/celltrion-receives-positive-chmp-opinion-233300267.html
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Top 5 Most-Read Regulatory Articles of 2024
December 25th 2024In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
